Pharmacovigilance

Integrated mechanisms and processes for monitoring the safety of medicines are essential to a well-functioning pharmaceutical sector. A positive benefit-to-risk balance should precede access to market; however, most regulatory decisions take place early in the product lifecycle and are based on limited data from clinical trials that may be of relatively short duration with limited numbers and types of subjects.

It is critical, therefore, that medicines continue to be monitored for safety and effectiveness once they enter the market under real-life conditions. For some medicines, issues will only emerge under real-world conditions as a result of prolonged use, use in specific subpopulations or in patients with multiple comorbidities, or use in combination with other medicines. In some cases, rare adverse effects only emerge after a product is used for many years, by large numbers of patients, or both. The activities related to the detection, assessment, understanding, and prevention of these adverse effects are known collectively as pharmacovigilance (PV).[1]

As part of its efforts to increase access to essential medicines, SIAPS worked to establish and strengthen PV systems in low- and middle-income countries, where mechanisms to ensure medicine safety are often inadequate or under-resourced. Recognizing that even relatively rare problems associated with medicine use can have a major impact on patient safety, prescriber behavior, patient adherence, and overall health outcomes, SIAPS used a systems-based approach to support countries in understanding and establishing both passive and active approaches to the identification of medicine-related problems.

Importantly, medicine-related problems are not limited to adverse drug reactions. They can also include the adverse effects of medication errors and product quality issues. Viewing PV through a systems-strengthening lens allowed SIAPS to ensure that these activities were harmonized with other components of the pharmaceutical system, including regulatory approval processes; medicines selection, procurement, and distribution; and clinical treatment guidelines. To that end, SIAPS looked for opportunities to engage in effective PV practices at multiple entry points—at premarket evaluation, at the facility level, in clinics, and even in patients’ homes—and to ensure that even the most decentralized mechanisms can usefully be aggregated and feed a larger, comprehensive PV framework.

By using its Integrated Pharmacovigilance Assessment Tool, SIAPS helped a number of low- and middle-income countries assess their existing PV processes, structures, and capacity to identify strengths, weaknesses, and gaps. Selected interventions and results included:

  • Supporting the implementation of a decentralized PV system in South Africa that has successfully collected data on adverse events since 2010
  • Initiating sentinel site-based surveillance systems in Swaziland and Namibia to enable the collection of comprehensive adverse event data on antiretrovirals and TB medicines
  • Developing and implementing a PV strategy for the national TB program in Ukraine to improve reporting and capture of adverse event data, expand active surveillance, and conduct quality checks

By strengthening PV systems in parallel with efforts to make medicines more widely available, SIAPS worked to ensure medicine safety, refine medicine selection, and support the collection of data to inform decision making at all levels of the health system. In this way, improved availability of medicines can be supported by more robust health systems and ensure delivery of better health outcomes.

[1] Definition adapted from the World Health Organization: http://www.who.int/medicines/areas/quality_safety /safety_efficacy/pharmvigi/en/